The clot stabilizer tranexamic acid performed no better than placebo when administered prophylactically to prevent bleeding in patients with hematologic malignancies who also received routine prophylactic platelet transfusions, according to findings presented by Terry B. Gernsheimer, MD, and colleagues at a press briefing in advance of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 2). Researchers cautioned that the study’s focus is different from other situations in which tranexamic acid has been found effective, such as its use in treating bleeding related to childbirth, surgery, or inherited blood disorders.
Terry B. Gernsheimer, MD
“Clearly, patients with low platelet counts and blood cancers have a different kind of bleeding than the bleeding experienced by patients who have suffered some kind of trauma or surgery,” said senior study author Dr. Gernsheimer, of the University of Washington School of Medicine. “Their bleeding likely is due to endothelial damage—damage to the lining of blood vessels—that tranexamic acid would not treat. To prevent bleeding in these patients, we may need to look at ways to speed the healing of the endothelium that occurs with chemotherapy, radiation, and graft-vs-host disease in patients receiving a transplant.”
Bleeding in Patients With Hematologic Malignancies
Between 48% and 70% of patients undergoing treatment for blood cancers experience bleeding complications of World Health Organization grade 2 or higher. Though not life-threatening, grade 2 bleeding can be concerning; bleeding of grade 3 or 4 can be life-threatening and warrant blood transfusions. Most patients undergoing treatment for blood cancers are routinely given platelet transfusions to prevent bleeding, but many continue to experience bleeding episodes.
Study Methods and Findings
To determine whether tranexamic acid could help to further reduce bleeding in these patients, the researchers enrolled 327 patients undergoing treatment for blood cancers at three U.S. medical centers. Half were randomly assigned to receive tranexamic acid, and half received a placebo, administered either orally or intravenously three times a day until they recovered their platelet count or for up to 30 days. Researchers regularly followed up with participants to assess bleeding events both in and outside of the hospital.
The results revealed no significant differences among the study groups in terms of number of bleeding events, number of red blood cell transfusions, or number of platelet transfusions patients required during the treatment period and for up to 14 days afterward. Patients receiving tranexamic acid had a significantly higher rate of occlusions in their central venous line, which required clearing with a clot-dissolving drug, but there was no difference in the occurrence of clots in patients’ veins or arteries.
Dr. Gernsheimer noted that other studies could help elucidate whether the drug may be helpful for specific subgroups of patients with blood cancers or as a treatment for bleeding, rather than as a preventive measure in these patients. It may also be useful to prevent or treat bleeding in patients with other causes of low platelet counts.
The study authors concluded, “Prophylactic tranexamic acid has no effect on the incidence of World Health Organization grade 2+ bleeding when given in addition to routine platelet transfusions to severely thrombocytopenic patients undergoing therapy for hematologic malignancy. An increased incidence of line occlusion in the tranexamic acid arm was observed, but no increase in other types of thrombotic events was detected.”
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
